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. 2023 Sep 11;330(11):1054–1063. doi: 10.1001/jama.2023.15694

Table 2. Key Secondary Outcome Analysis.

Outcome No./total (%) Risk difference, % (95% CI)a Relative risk (95% CI)a P valueb
Minimally invasive surfactant therapy (n = 224) Control treatment (n = 229)
Death or neurodevelopmental disabilityc,d,e 78/215 (36.3) 79/219 (36.1) 0.0 (−7.6 to 7.7) 1.00 (0.81 to 1.24) .99
Death prior to 2 y corrected age 29/224 (12.9) 24/229 (10.5) 2.4 (−3.6 to 8.4) 1.23 (0.69 to 2.19) .48
Neurodevelopmental disabilityc,d,e 49/186 (26.3) 55/195 (28.2) −1.6 (−9.4 to 6.2) 0.94 (0.71 to 1.25) .69
a

Adjusted for gestational age group.

b

P value for relative risk derived from generalized linear model.

c

Neurodevelopmental disability, defined as any of (1) moderate to severe cognitive or language impairment; (2) cerebral palsy equivalent to Gross Motor Function Classification System ≥220; (3) visual impairment; and (4) hearing impairment. See eTable 1 in Supplement 3 for further details of the approach to outcome ascertainment with the different modalities of data capture.

d

Key secondary outcome not determinable from available follow-up data in 9 of 224 infants in the minimally invasive surfactant therapy group and 10 of 229 infants in the control group.

e

Neurodevelopmental disability assessment at 2 years was by online questionnaire including Parent Report of Children’s Abilities–Revised in 315 infants (minimally invasive surfactant therapy: 152, control: 163, including 64 and 69 cases, respectively, in which the questionnaire was administered using a translated version). Other modes of follow-up were face-to-face assessment including Bayley Scales of Infant and Toddler Development, Third Edition in 38 infants (minimally invasive surfactant therapy: 19, control: 19), abbreviated questionnaire in 25 (minimally invasive surfactant therapy: 14, control: 11), and a combination of modalities in 3 (minimally invasive surfactant therapy: 1, control: 2).